Senior Quality Engineer – Complaints Handling

About the role

The Senior Quality Engineer will lead complaint handling and product investigations for medical devices, ensuring compliance with regulatory standards and driving continuous improvement.

Key responsibilities

• Manage complaint files, perform visual, functional, and dimensional inspections, and conduct root cause analysis of field‑returned products.
• Lead risk assessments, review process flows, DHRs, inspection plans, and identify non‑conformities and CAPA opportunities.
• Create PMS plans, PSUR reports, trend analyses, and complaint analysis in line with EUMDR guidelines.
• Provide technical guidance, promote best practices, and mentor cross‑functional teams.

Required profile

• B.Tech/M.Tech in Mechanical, Biotechnology or related field with 5‑7 years of relevant experience.
• Hands‑on experience with ISO 14971 risk management, ISO 9001/13485, and FDA 21CFR Part 822/820.
• Strong analytical ability, proficiency in root cause analysis, 7 QC tools, and CAPA processes.

Required skills

• Visual, functional and dimensional inspection
• Root cause analysis (RCA)
• Risk management (ISO 14971)
• ISO 9001 & ISO 13485 compliance
• FDA 21CFR Part 822/820 knowledge
• 7 QC tools and CAPA implementation
• Engineering drawing interpretation